Arrow-Trerotola Percutaneous Thrombolytic Device or Ptd

• 7 recalls, same reason

  • Terminated Z-0624-2022 FDA Class I ·initiated 11 Jan 2022
  • Terminated Z-0629-2022 FDA Class I ·initiated 11 Jan 2022
  • Terminated Z-0625-2022 FDA Class I ·initiated 11 Jan 2022
  • Terminated Z-0626-2022 FDA Class I ·initiated 11 Jan 2022
  • Terminated Z-0628-2022 FDA Class I ·initiated 11 Jan 2022
  • Terminated Z-0623-2022 FDA Class I ·initiated 11 Jan 2022
  • Terminated Z-0627-2022 FDA Class I ·initiated 11 Jan 2022

  The firm received reports indicating PTD tip separation during use.

• 4 recalls, same reason

  • Terminated Z-0231-2022 FDA Class I ·initiated 20 Sep 2021 ·on shared 510(k) K011056
  • Terminated Z-0233-2022 FDA Class I ·initiated 20 Sep 2021 ·on shared 510(k) K011056
  • Terminated Z-0234-2022 FDA Class I ·initiated 20 Sep 2021 ·on shared 510(k) K011056
  • Terminated Z-0232-2022 FDA Class I ·initiated 20 Sep 2021 ·on shared 510(k) K011056

  7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

• • Terminated Z-1502-2009 FDA Unclassified (pre-2012) ·initiated 11 Feb 2009 ·on shared 510(k) K011056

  Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

• • Terminated Z-0842-05 FDA Unclassified (pre-2012) ·initiated 18 Mar 2005 ·on shared 510(k) K011056

  The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K011056 ↗

FDA Product Code

QEW

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

See all devices from Arrow Intl., Inc. →